Label: SLEEP AID- diphenhydramine hcl 25 mg tablet

  • NDC Code(s): 72090-020-10
  • Packager: Pioneer Life Sciences, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 24, 2024

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each caplet)

    Diphenhydramine HCl 25mg

  • Purpose

    Night Time Sleep Aid

  • Uses:

    for relief of occasional sleeplessness

  • Warnings:

    Do not use:

    ■ in children under 12 years of age ■with any other product containing diphenhydramine, even one used on skin.

  • ASK DOCTOR

    Ask a doctor before use if you have:

    ■ a breathing problem such as, emphysema or chronic bronchitis

    ■ glaucoma

    ■ trouble urinating due to an enlarged prostate gland.

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:■taking sedatives or tranquilizers.

  • WHEN USING

    When using this product:

    ■ avoid alcoholic drinks
    ■ drowsiness will occur 

    ■ do not drive a motorvehicle or operate machinery.

  • STOP USE

    Stop use and ask a doctor if:

    ■ sleeplessness persist continuously for more than 2 weeks. Insomnia may be a symptom of serious underlying medical illness.

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding,ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Overdose Warning:In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222).

  • DIRECTIONS

    do not take more than directed(See overdose warning) 

    ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor

    ■ children under 12 years: do not use

  • OTHER INFORMATION

    ■each caplet contains: calcium 23.52 mg

    ■store between 15-30°C (59-86°F).

    ■Avoid high humidity.

    ■ Protect from light.

  • INACTIVE INGREDIENTS

    Colloidal Silicon, Croscarmellose, Sodium, Dicalcium Phosphate, FD&C Blue#1, FD&C Blue#2, Lethicin, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl Alcohol , Titanium Dioxide, Talc.

  • QUESTIONS OR COMMENTS?

    Call toll free 1-732-698-5070 Mon to Fri 9am – 5pm.

  • PRINCIPAL DISPLAY PANEL

    Sleep-Aid-Regular Strength-100ct

  • INGREDIENTS AND APPEARANCE
    SLEEP AID 
    diphenhydramine hcl 25 mg tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72090-020
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorblueScoreno score
    ShapeCAPSULESize11mm
    FlavorImprint Code S5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72090-020-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01006/29/2020
    Labeler - Pioneer Life Sciences, LLC (014092742)